[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"drug-pretomanid":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":16,"formulations":18,"regimens":33,"contraindications":61,"warnings":71,"renal":79,"monitoring":80,"interactions":81,"review":82,"examples":85,"atc":91,"iran":93,"usApproval":100,"links":106,"populations":120},"pretomanid",1,{"fa":7,"en":8},"پرتومانید","Pretomanid","anti-infectives",{"fa":11,"en":12},"نیتروایمیدازوکسازین (ضدسل)","Nitroimidazooxazine (antimycobacterial)",[14],{"name":8,"market":15},"US",[4,7,17],"BPaL",[19],{"id":20,"form":21,"route":22,"label":23,"concentration":24,"markets":28,"refs":29},"tab-200","tablet","oral","200 mg tablet",{"amount":25,"unit":26,"perUnit":21,"scored":27},200,"mg",false,[15],[30],{"source":31,"section":32},"fda-pretomanid","3",[34],{"id":35,"disease":36,"label":37,"population":40,"type":44,"unit":26,"dose":45,"refs":46,"notes":49},"mdr","tuberculosis",{"fa":38,"en":39},"سل ریوی مقاوم (XDR یا MDR غیرپاسخ‌دهنده) — ۲۰۰ mg یک بار در روز ۲۶ هفته همراه بداکیلین و لینزولید","Pulmonary XDR or treatment-intolerant\u002Fnon-responsive MDR-TB — 200 mg once daily for 26 weeks with bedaquiline and linezolid",{"minAge":41},{"value":42,"unit":43},18,"year","fixed",{"perDose":25,"dosesPerDay":5},[47],{"source":31,"section":48},"2.2",[50],{"text":51,"refs":54},{"fa":52,"en":53},"فقط همراه بداکیلین و لینزولید، با غذا، تحت DOT. پیش از شروع آزمایش کبد، CBC، ECG و الکترولیت. اگر بداکیلین یا پرتومانید قطع شود کل رژیم قطع.","Only with bedaquiline and linezolid, with food, under DOT. Liver tests, CBC, ECG and electrolytes before starting. If bedaquiline or pretomanid stops, stop the whole regimen.",[55,57,59],{"source":31,"section":56},"2.1",{"source":31,"section":58},"2.3",{"source":31,"section":60},"2.4",[62],{"id":63,"severity":64,"text":65,"refs":68},"ci","block",{"fa":66,"en":67},"هر منع مصرف بداکیلین یا لینزولید.","Any contraindication to bedaquiline or linezolid.",[69],{"source":31,"section":70},"4",[72],{"text":73,"refs":76},{"fa":74,"en":75},"سمیت کبدی؛ سرکوب مغز استخوان؛ نوروپاتی محیطی و بینایی؛ طولانی شدن QT؛ اسیدوز لاکتیک؛ اثر بر باروری مردان.","Hepatotoxicity; myelosuppression; peripheral and optic neuropathy; QT prolongation; lactic acidosis; male reproductive effects.",[77],{"source":31,"section":78},"5",[],[],[],{"status":83,"reviewer":84,"date":84},"unverified",null,[86],{"regimen":35,"formulation":20,"input":87,"expect":90},{"ageYears":88,"weightKg":89},35,60,{"perDose":25,"tabletsPerDoseRounded":5},[92],"J04AK08",{"status":94,"refs":95},"not-found",[96],{"source":97,"section":98,"url":99},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Pretomanid",{"kind":101,"refs":102,"id":105},"NDA",[103],{"source":31,"section":104},"SPL approval \u002F marketing category","NDA212862",[107,110,114,117],{"kind":108,"url":109,"label":105},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212862",{"kind":111,"url":112,"label":113},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=f1906fc9-cb3c-4e13-8a4a-da76100c1bf3","FDA Pretomanid",{"kind":115,"url":116,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa619056.html",{"kind":118,"url":119,"label":92},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=J04AK08",{"pregnancy":121,"lactation":130,"pediatric":138,"geriatric":147,"reproductive":155},{"level":122,"text":123,"quote":126,"refs":127},"caution",{"fa":124,"en":125},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary There are no studies or available data on pretomanid use in pregnant women to inform any drug-associated risks.",[128],{"source":31,"section":129},"8.1",{"level":122,"text":131,"quote":134,"refs":135},{"fa":132,"en":133},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary There is no information regarding the presence of pretomanid in human milk, or its effects on milk production or the breastfed infant.",[136],{"source":31,"section":137},"8.2",{"level":139,"text":140,"quote":143,"refs":144},"not-established",{"fa":141,"en":142},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness of Pretomanid Tablets in pediatric patients have not been established.",[145],{"source":31,"section":146},"8.4",{"level":122,"text":148,"quote":151,"refs":152},{"fa":149,"en":150},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","Clinical studies of the combination regimen of Pretomanid Tablets, bedaquiline, and linezolid did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.",[153],{"source":31,"section":154},"8.5",{"level":122,"text":156,"quote":159,"refs":160},{"fa":157,"en":158},"برچسب نکته‌ای درباره بارداری، پیشگیری یا باروری زنان و مردان دارد.","Label has advice on pregnancy testing, contraception or fertility for females and males.","Infertility Males Reduced fertility and\u002For testicular toxicity were observed in male rats and mice treated with oral pretomanid.",[161],{"source":31,"section":162},"8.3",1792444418932]